Site University College London Hospitals NHS Foundation Trust Town London Salary £66,274 – £73,496 Per annum inclusive of HCAS Salary period Yearly Closing 05/07/2026 23:59
Job overview
This is an exciting opportunity to join a growing pharmaceutical regulatory function within UCL. The role is a Regulatory Manager – Pharmaceuticals position, responsible for supporting the next generation of groundbreaking therapies and technologies.
We are looking for a highly specialist pharmacist with experience in clinical trials, pharmaceutical manufacturing, or regulatory affairs, who is passionate about advancing clinical research and helping bring innovative therapies from development to patients.
Main duties of the job
The post holder will provide expert regulatory, pharmaceutical and IMP support for UCL-sponsored CTIMPs, particularly studies where the Sponsor is responsible for IMP manufacture and supply.
Responsibilities include:
- Developing CMC strategies, including manufacturing, testing, release and supply chain models.
- Identifying suitable pharmaceutical vendors and CDMOs.
- Determining CTA documentation requirements based on study phase, product type and complexity.
- Reviewing and approving GMP and pharmaceutical documentation.
- Supporting responses to regulatory authority queries.
- Providing advice on complex CMC and regulatory challenges.
- Leading the development and review of quality agreements.
- Overseeing outsourced manufacturing and testing activities.
- Acting as a key point of contact for investigators, trial teams, manufacturers and site pharmacies on pharmaceutical and regulatory matters.
- Participating in the UCL JRO Scope Review Committee to classify studies as CTIMPs or non‑CTIMPs.
- Subject to funding, undertaking national and international travel, including GMP audits and due diligence assessments.
Person specification
Specific Requirements
- Ability to travel between UCH and UCL sites if required.
- Ability to travel to external vendors/CMO sites nationally and internationally as and when required.
Knowledge and Qualifications
- Masters Degree (or equivalent) in Pharmacy.
- Knowledge of Clinical Trials regulations gained through pharmacy or equivalent work experience.
- Knowledge of the processes required to set up and conduct clinical trials from IMP sourcing, manufacturing or management perspective.
Experience
- Significant hospital pharmacy experience acquired through post‑registration work.
- GMP and/or GCP experience gained in hospital or pharmaceutical industry.
- Familiarity with aseptic preparation and/or sterile manufacturing processes.
- Documented commitment to continued professional development.
- Experience working with innovative medicines including ATMPs.
Skills and Abilities
- Trained in principles of Good Clinical Practice and Good Manufacturing Practice.
- Ability to formulate suitable solutions where current practice and evidence is uncertain.
- Ability to work without supervision and use own initiative.
Values
- Demonstrate ability to meet Trust Values of safety, kindness, teamwork and improving.
Communication
- Excellent verbal and written communication skills.
Legal and immigration requirements
You must already have the right to work in the United Kingdom or fully meet the eligibility criteria for sponsorship under the Skilled Worker visa route. Applications that do not meet UKVI requirements cannot be processed.
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